Bayer and MassBio® today announced the Center for Regulatory Excellence, a first-of-its-kind forum for startups and academia to interact with and learn from regulatory experts. The Center for Regulatory Excellence will provide formal mentorship and regular seminars to ensure early identification and mitigation of regulatory issues and optimize the chances of regulatory success.
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“Many early-stage startups and academics have a limited understanding of regulatory science, which can become a major roadblock in the drug development process. The Center for Regulatory Excellence will infuse startups with critical information at an early stage of development and reinforces Bayer’s exceptional commitment to MassBio’s MassCONNECT® program and open innovation,” said John Hallinan, Chief Business Officer, MassBio. “The Center will help entrepreneurs define a pathway and formulate a plan that will save countless amounts of time and money and provide earlier access for patients.”
The Center for Regulatory Excellence will serve the exclusive needs of MassCONNECT graduates – and as in the case for the Bayer Fellowship program – is an extension of MassCONNECT, MassBio’s premier mentorship for the life sciences industry. The Center will host regular seminars that will be open to all startups in the biotech and digital health space. Each session will focus on specific areas of interest related to the regulatory process and will entail lectures, open dialogue, and networking.
“The already complex regulatory landscape is becoming increasingly challenging with the evolving regulatory frameworks for new technologies and the overall digitization of regulatory operations,” said Max Wegner, Head of Regulatory Affairs at Bayer. “The launch of the Center for Regulatory Excellence provides a great opportunity to support talent development by sharing our experience. We hope this knowledge sharing activity will help these companies developing innovative products so eventually, the products can reach patients.”
Bayer has had hundreds of drugs approved in various combinations and indications throughout the world. Bayer is currently present in 90 countries and has worked with each of these country’s regulatory bodies to gain approval of therapeutic products. These regulatory approvals include both small molecule and biological products, and cover a wide range of therapeutic areas including cardiovascular, oncology, ophthalmology, hemophilia, and hormonal contraceptives. With this vast experience, Bayer’s regulatory affairs experts are well attuned to the dynamic regulatory landscape that is ever evolving to keep pace with advancements in science and innovation.
“The future success of the biopharma industry is dependent on a strong startup community, and with a constantly shifting regulatory landscape it becomes increasingly challenging for entrepreneurs to have the resources and expertise to commercialize their idea so it eventually reaches patients in need,” said Chandra Ramanathan, Global Head of R&D Open Innovation at Bayer. “Bayer and MassBio have recognized a greater need for regulatory guidance for entrepreneurs and Bayer is committed to providing that expertise as part of our long-standing commitment to fostering innovation in Massachusetts and beyond.”
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.com.
MassBio is a not-for-profit organization founded in 1985 that represents and provides services and support for the Massachusetts life sciences industry. MassBio is committed to advancing Massachusetts’ leadership in the life sciences to grow the industry, add value to the healthcare system and improve patient lives. Representing more than 1,300+ biotechnology companies, academic institutions, research hospitals, and service organizations involved in life sciences and healthcare, MassBio works to advance policy and promote education, while providing member programs, events, industry information, and services. Learn more at www.massbio.org.